Asenapine side effects: what 886 FDA adverse event reports show

Asenapine · 66 reaction terms · 970 drug–reaction co-reports · data 2026-09-14

Drug class

Atypical Antipsychotic

FDA label (Established Pharmacologic Class) · compare the class

Who reports

886 reports · 79% serious · 138 with death outcome · 54% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Asenapine is indicated for: • Bipolar I disorder • Acute monotherapy of manic or mixed episodes, in pediatric patients 10 to 17 years of age • Adjunctive treatment to lithium or valproate in adults Asenapine is an atypical.

FDA label, Indications and Usage

What it is

Asenapine sublingual tablet contains asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles.

FDA label, Description section

Boxed warning

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Asenapine is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1, 5.2)].

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 39 strongest signals

Labeled — boxed warning 3Labeled adverse reaction 7Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 5Outcome field, not a reaction 1Not in label — unassessed 18

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 27 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Myocarditis	54	113.0 87.2–146.4ROR 120.3 · χ² 5,858 / p <1e-300	108.3 EB05 86.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 82.3	no trial data cached
Parkinsonism	16	38.8 23.8–63.0ROR 39.5 · χ² 551 / p 4e-122	37.1 EB05 24.2 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 32.7	no trial data cached
Akathisia (inner restlessness)	22	38.1 25.2–57.5ROR 39.0 · χ² 757 / p 6e-167	36.9 EB05 25.7 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.0	no trial data cached
Sedation	40	36.2 26.8–49.1ROR 37.9 · χ² 1,335 / p 1e-292	35.6 EB05 27.3 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 30.1	no trial data cached
Neuroleptic malignant syndrome	18	35.8 22.6–56.5ROR 36.5 · χ² 573 / p 6e-127	34.5 EB05 23.1 · IC025 +3.4 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 26.2	no trial data cached
Hallucination, auditory	24	35.6 24.0–52.9ROR 36.6 · χ² 773 / p 2e-170	34.7 EB05 24.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 30.0 · ♀ 33% (drug 54%)	no trial data cached
Mania	24	34.5 23.2–51.2ROR 35.4 · χ² 747 / p 9e-165	33.6 EB05 23.8 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.4 · 96% clinician	no trial data cached
Sinus tachycardia	20	33.3 21.6–51.4ROR 34.1 · χ² 595 / p 1e-131	32.4 EB05 22.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 24.8	no trial data cached
Schizophrenia	17	33.0 20.6–52.9ROR 33.6 · χ² 496 / p 4e-110	31.9 EB05 21.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 23.5	no trial data cached
Dystonia	26	31.5 21.6–46.1ROR 32.5 · χ² 738 / p 6e-163	30.9 EB05 22.1 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.5 · ♀ 86% (drug 54%) · 96% clinician	no trial data cached
Serotonin syndrome	23	28.4 19.0–42.5ROR 29.1 · χ² 581 / p 1e-128	27.8 EB05 19.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 20.9 · 100% clinician	no trial data cached
Salivary hypersecretion	11	26.0 14.4–46.8ROR 26.3 · χ² 240 / p 2e-54	24.8 EB05 14.6 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 23.4	no trial data cached
Delusion	17	25.9 16.2–41.5ROR 26.4 · χ² 383 / p 2e-85	25.2 EB05 16.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 22.8	no trial data cached
Eyelid oedema	12	24.2 13.8–42.5ROR 24.5 · χ² 244 / p 2e-55	23.3 EB05 13.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 25.9	no trial data cached
Extrapyramidal disorder	22	20.7 13.7–31.3ROR 21.2 · χ² 393 / p 8e-88	20.3 EB05 14.0 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.8 · 100% clinician	no trial data cached
Sexual dysfunction	10	20.2 10.9–37.4ROR 20.4 · χ² 164 / p 8e-38	19.0 EB05 10.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 22.0	no trial data cached
Completed suicide (death by suicide)	72	20.2 16.2–25.2ROR 21.9 · χ² 1,299 / p 1e-284	20.1 EB05 16.5 · IC025 +3.8 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 14.7 · ♀ 81% (drug 54%) · 97% clinician	no trial data cached
Paranoia	14	19.1 11.3–32.1ROR 19.4 · χ² 222 / p 2e-50	18.4 EB05 11.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.2	no trial data cached
Application site irritation	10	19.0 10.2–35.1ROR 19.2 · χ² 153 / p 2e-35	17.7 EB05 9.2 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious n=2	no trial data cached
Conjunctivitis	12	15.4 8.8–27.0ROR 15.6 · χ² 148 / p 3e-34	14.2 EB05 7.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 20.9	no trial data cached
Electrocardiogram qt prolonged	22	14.4 9.5–21.8ROR 14.8 · χ² 262 / p 3e-59	13.9 EB05 9.3 · IC025 +2.8 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 10.7 · 95% clinician	no trial data cached
Mental impairment	14	13.6 8.1–22.9ROR 13.8 · χ² 151 / p 4e-35	12.4 EB05 7.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 12.5	no trial data cached
Psychotic disorder	17	13.6 8.5–21.8ROR 13.8 · χ² 186 / p 1e-42	12.7 EB05 7.8 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 10.8	no trial data cached
Hallucination, visual	12	13.5 7.7–23.7ROR 13.7 · χ² 127 / p 1e-29	12.0 EB05 6.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Drug resistance	14	12.9 7.6–21.6ROR 13.1 · χ² 142 / p 6e-33	11.6 EB05 6.7 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 10.6	no trial data cached
Product substitution issue	31	12.7 9.0–18.0ROR 13.1 · χ² 324 / p 1e-72	12.3 EB05 8.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5	no trial data cached
Deafness	12	10.8 6.2–19.0ROR 10.9 · χ² 97 / p 3e-23	9.1 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Liver function test abnormal	12	9.7 5.5–17.0ROR 9.8 · χ² 85 / p 2e-20	7.9 EB05 4.5 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 8.8	no trial data cached
Toxicity to various agents	66	9.3 7.4–11.7ROR 9.9 · χ² 483 / p 2e-107	9.0 EB05 7.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.0 · 97% clinician	no trial data cached
Rhabdomyolysis (muscle breakdown)	16	9.1 5.6–14.7ROR 9.2 · χ² 107 / p 2e-25	7.8 EB05 4.9 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.7	no trial data cached
Restlessness	14	9.0 5.4–15.2ROR 9.1 · χ² 92 / p 4e-22	7.6 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Dyskinesia (involuntary movements)	15	8.7 5.3–14.4ROR 8.9 · χ² 95 / p 9e-23	7.4 EB05 4.6 · IC025 +1.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 8.1	no trial data cached
Suicidal ideation (thoughts of suicide)	32	8.2 5.9–11.6ROR 8.5 · χ² 197 / p 4e-45	7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.2 · ♀ 24% (drug 54%)	no trial data cached
Drug effective for unapproved indication	10	8.1 4.4–15.0ROR 8.2 · χ² 55 / p 6e-14	6.3 EB05 3.5 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious n=10	no trial data cached
Disease recurrence	16	7.9 4.9–12.9ROR 8.0 · χ² 90 / p 1e-21	6.7 EB05 4.3 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 11.4	no trial data cached
Abnormal behaviour	11	6.5 3.6–11.7ROR 6.6 · χ² 46 / p 6e-12	5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 3.6	no trial data cached
Suicide attempt	16	6.2 3.8–10.1ROR 6.3 · χ² 65 / p 4e-16	5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.5	no trial data cached
Aggression	12	5.6 3.2–9.9ROR 5.7 · χ² 41 / p 6e-11	4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 3.4	no trial data cached
Drug abuse	14	3.9 2.3–6.6ROR 4.0 · χ² 28 / p 6e-8	3.5 EB05 2.3 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Completed suicide (death by suicide)	72	20.2 16.2–25.2ROR 21.9 · χ² 1,299 / p 1e-284	20.1 EB05 16.5 · IC025 +3.8 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 14.7 · ♀ 81% (drug 54%) · 97% clinician	no trial data cached
Toxicity to various agents	66	9.3 7.4–11.7ROR 9.9 · χ² 483 / p 2e-107	9.0 EB05 7.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.0 · 97% clinician	no trial data cached
Myocarditis	54	113.0 87.2–146.4ROR 120.3 · χ² 5,858 / p <1e-300	108.3 EB05 86.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 82.3	no trial data cached
Sedation	40	36.2 26.8–49.1ROR 37.9 · χ² 1,335 / p 1e-292	35.6 EB05 27.3 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 30.1	no trial data cached
Suicidal ideation (thoughts of suicide)	32	8.2 5.9–11.6ROR 8.5 · χ² 197 / p 4e-45	7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.2 · ♀ 24% (drug 54%)	no trial data cached
Product substitution issue	31	12.7 9.0–18.0ROR 13.1 · χ² 324 / p 1e-72	12.3 EB05 8.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5	no trial data cached
Dystonia	26	31.5 21.6–46.1ROR 32.5 · χ² 738 / p 6e-163	30.9 EB05 22.1 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.5 · ♀ 86% (drug 54%) · 96% clinician	no trial data cached
Mania	24	34.5 23.2–51.2ROR 35.4 · χ² 747 / p 9e-165	33.6 EB05 23.8 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.4 · 96% clinician	no trial data cached
Hallucination, auditory	24	35.6 24.0–52.9ROR 36.6 · χ² 773 / p 2e-170	34.7 EB05 24.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 30.0 · ♀ 33% (drug 54%)	no trial data cached
Serotonin syndrome	23	28.4 19.0–42.5ROR 29.1 · χ² 581 / p 1e-128	27.8 EB05 19.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 20.9 · 100% clinician	no trial data cached
Electrocardiogram qt prolonged	22	14.4 9.5–21.8ROR 14.8 · χ² 262 / p 3e-59	13.9 EB05 9.3 · IC025 +2.8 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 10.7 · 95% clinician	no trial data cached
Extrapyramidal disorder	22	20.7 13.7–31.3ROR 21.2 · χ² 393 / p 8e-88	20.3 EB05 14.0 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.8 · 100% clinician	no trial data cached
Akathisia (inner restlessness)	22	38.1 25.2–57.5ROR 39.0 · χ² 757 / p 6e-167	36.9 EB05 25.7 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.0	no trial data cached
Sinus tachycardia	20	33.3 21.6–51.4ROR 34.1 · χ² 595 / p 1e-131	32.4 EB05 22.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 24.8	no trial data cached
Neuroleptic malignant syndrome	18	35.8 22.6–56.5ROR 36.5 · χ² 573 / p 6e-127	34.5 EB05 23.1 · IC025 +3.4 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 26.2	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Myocarditis — n=54, PRR 113.0
Hallucination, auditory — n=24, PRR 35.6
Sinus tachycardia — n=20, PRR 33.3
Serotonin syndrome — n=23, PRR 28.4
Toxicity to various agents — n=66, PRR 9.3

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Asenapine?

In FDA FAERS, the most frequently co-reported reaction terms for Asenapine are toxicity to various agents, myocarditis, sedation, suicidal ideation, dystonia, mania. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Asenapine have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Asenapine is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1, 5.2)].

Do FAERS signals prove that Asenapine causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID cf587c48-9cd2-4dc5-b0e9-21783c5633a6, effective 20230120; matched on openfda.generic_name.exact:"ASENAPINE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 66 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.